Home NDC 69488-001 NETSPOT
Product NDC 69488-001
11-digit product format 694880001
Labeler code 69488
Product ID 69488-001_9e573457-066c-46b8-9a26-b99ec4e796e6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name 68Ga-DOTATATE
Dosage form KIT
Route INTRAVENOUS
Labeler Advanced Accelerator Applications USA, Inc
Application NDA208547
Marketing category NDA
Marketing start 2016-06-01
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208547-001 NETSPOT GALLIUM DOTATATE GA-68 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208547-001 9375498 2032-08-10 Drug product 2018-07-09
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208547-001 NETSPOT 2.1-5.5mCi/ML POWDER / INTRAVENOUS RLD, RS 2016-06-01 f41ea6bd6efb…
Observed Orange Book patent history# Patent history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N208547-001 9375498 2032-08-10 Drug product 2018-07-09 f41ea6bd6efb…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base NETSPOT
Listing expiration 2027-12-31 Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69488-001-40 NETSPOT 1 in 1 KIT KIT 1 22
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69488-001 NETSPOT (68GA-DOTATATE) KIT [ADVANCED ACCELERATOR APPLICATIONS USA, INC] 20 Current NDC, Legacy NDC, 1 package rows 20240801_b2b3be70-17d8-4093-896c-f1c54a2cf242.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NETSPOT 68GA-DOTATATE Advanced Accelerator Applications USA, Inc b2b3be70-17d8-4093-896c-f1c54a2cf242 2026-07-06 Warnings, Adverse reactions Exact identifier application applno (NDA): 208547 application number: NDA208547 ndc (product): 69488-001
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69488-001-40 69488000140 1 KIT in 1 KIT (69488-001-40) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 1 kit 2016-06-01 0000-00-00 No No Current